Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC

Conditions

• Advanced Breast Cancer
• Breast Cancer
• Hormone-receptor-positive Breast Cancer
• Human Epidermal Growth Factor 2 Low Breast Cancer
• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab govitecan — DRUG
  IV infusion of 10 mg/kg on Days 1 and 8 of each continuous and consecutive 21-day cycles. The first infusion will last approximately 3 hours and subsequent infusions will last 1-2 hours if prior infusions were well tolerated.

Study Details

The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.

Key Dates

First listed

Feb 16, 2024

Start date

Jun 17, 2024

Status verified

Aug 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sacituzumab Govitecan (SG) Infusion
  SG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

• Reshma L Mahtani, D.O.
  (786) 596-2000
  [email protected]
• Krystal Fernandez
  (786) 596-2000
  [email protected]

Locations (3)

Find similar trials in Miami, FL

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